Study in Healthy Volunteers to Assess the Pharmacokinetics of Midazolam Administered Alone and in Combination With Vandetanib
Completed · Phase 1
Conditions studied: Healthy Volunteers
In brief
The purpose of this study in healthy volunteers is to assess the Pharmacokinetics (PK) of Midazolam administered alone and in combination with Vandetanib.
Key facts
- Study ID
- NCT01544140
- Run by
- Sanofi
- People needed
- 16
- Starts
- 2012-04-01
- Expected to finish
- 2012-07-01
- Last updated by the study team
- 2016-08-29
Who can join
Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Provision of signed and dated, written informed consent prior to any study
- specific procedures:
- Volunteers must be males or females aged 18 to 50 years and with a weight of at least 50 kg and body mass index (BMI) between 18 and 30 kg/m2, inclusive
- Females must have a negative pregnancy test at screening and on admission to the study center.
- Females must not be lactating and must be of non-childbearing potential defined as postmenopausal or documentation of irreversible surgical sterilization.
You may not qualify if…
- History of any clinically significant disease or disorder such as gastrointestinal, hepatic, renal or skin disease.
- History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity,
- Volunteers who smoke more than 5 cigarettes per day or are unable to refrain from smoking while resident in the study center
- Screening blood pressure of greater than 140/90 mmHg and/or a resting heart rate of less than 45 beats per minute (repeat test allowed at the Investigator's discretion)
- Clinically significant abnormal12-lead ECG as assessed by the Investigator,
- QTcF interval greater than 450 ms
- Any positive result on screening for:
- serum hepatitis B surface antigen,
- hepatitis C antibody, and
- human immunodeficiency virus (HIV), or
- Positive screen for drugs of abuse.
Where it is running
- Research Site — Overland Park, Kansas, United States
Full record on ClinicalTrials.gov
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